Permanent
Quality Engineer
Inchinnan

External Quality Engineer

Ref: 63| Posted: 28th Nov 2022

Terumo Aortic requires an External Quality Engineer, the successful individual will be required to provide External Quality Engineering support and work closely with the Quality manger to support the wider business. This is an excellent opportunity for someone looking to add real value whilst developing their career.

The Key Duties of the role are;

  • Provide Quality Engineering support to TAG Quality processes in relation to TVC, TAS and OEM activities
  • Support TAG Quality change management between sites
  • Provides support for manufacturing transfers between Terumo sites
  • Dedicated support for Quality projects
  • Ensure that all related processes and procedures meet the requirements of all applicable regulatory standards including the EU Medical Device Regulation (MDR); ISO 13485, 21 CFR Part 820, MDSAP requirements and other regulations as appropriate
  • Ensure that all related processes and procedures meet the requirements of all applicable regulatory standards including the EU Medical Device Regulation (MDR); ISO 13485, 21 CFR Part 820, MDSAP requirements and other regulations as appropriate
  • Support for future transfers, OEM customers and resultant ongoing BAU

The successful candidate will possess;

           Relevant science/engineering degree.

  • Proven experience in Quality Management Systems in a similar role within a medical device environment
  • Thorough knowledge of regulatory standards, Quality Management Systems, and global regulations for medical devices
  • Strong analytical and problem-solving skills
  • Excellent facilitation, coordination, prioritising, presentation, and communication skills
  • Proven ability to manage and prioritise workload, meet deadlines and work in a pressurised environment
  • Competence in the use of IT technology, such as Microsoft Office applications, and ability to learn other IT systems as appropriate